Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

November 2, 2017
Sándor Kemény

Sándor Kemény* is an emeritus professor at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering.

,
Máté Mihalovits

Máté Mihalovits is a PhD student at Budapest University of Technology and Economics.

Pharmaceutical Technology, Pharmaceutical Technology-11-02-2017, Volume 41, Issue 11
Page Number: 46-53

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

Abstract

The regulation of pharmaceutical stability studies still lacks universally accepted techniques regarding the identification of out-of-trend data. Three methods have been suggested for identifying out-of-trend data in pharmaceutical stability studies: the regression control chart, the by-time-point method, and the slope control chart. In Part I of this article series, the regression control chart method is investigated, and an improved approach is suggested. The method is illustrated using realistic data. In Part II, the by-time-point method and the multivariate control chart method will be discussed.

Peer-Review Article
Submitted: March 22, 2017
Accepted: June 27, 2017

About the Authors

Máté Mihalovits is a PhD student, mihalovits@mail.bme.hu; and Sándor Kemény* is an emeritus professor, Tel.: +36 309936307, kemeny@mail.bme.hu, both at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering Hungary, 1111. Budapest, Műegyetem rakpart 3.

* To whom all correspondence should be addressed.

Article Details

Pharmaceutical Technology
Vol. 41, No. 11
November 2017
Pages: 46–53

Citation:

When referring to this article, please cite it as M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart," Pharmaceutical Technology 41 (11) 2017.

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